The House Energy and Commerce Committee is hearing from biomedical experts as it seeks to authorize legislation that would establish the Advanced Health Research Projects Agency.
The White House and some members of Congress pushed to create an agency for advanced health and biomedicine research last year. Now that members of Congress have begun considering funding to set up the new agency, Congress is considering how to structure the mission and governance behind it.
The idea behind the Advanced Research Projects for Health Agency – dubbed ARPA-H – began when President Joe Biden proposed creating the agency in the White House’s fiscal year 2022 budget, requesting 6 $.5 billion over three years for ARPA-H. He proposed that the agency serve as a high-risk, high-reward biomedical research agency, modeled on the Military Advanced Research Projects Agency for Defense.
Now that members of Congress have begun including support for ARPA-H and health advancements through the 21st Century Cures 2.0 Act and the ARPA-H Act, the House Energy and Commerce Committee held a hearing last week to make research agency moonshot a reality.
Representative Anna Eshoo, who chairs the health subcommittee and introduced the ARPA-H bill, argued that biomedical research is currently divided between the basic research that the National Institutes of Health has long led and the biomedical innovation landscape led by companies aiming to commercialize scientific data. discoveries with commercial potential. She said ARPA-H will bridge the gaps between the two by spurring new innovations beyond the risk taken by NIH and private industry.
“My legislation proposes that ARPA-H be composed of highly empowered program managers who are not career government employees, but rather experts in their field, who dedicate their time to short-term projects for results long-term,” Eshoo said.
Those who testified before the subcommittee generally argued for the creation of ARPA-H, but each expert in biomedical research offered different thoughts on the governance, independence, and structure of the ARPA-H. ‘agency.
On the one hand, the current legislation supporting ARPA-H seeks to integrate it into the NIH as an independent agency. While some panelists supported this decision, others said that given the separate nature of NIH and ARPA-H, independence would be confusing.
“I believe it would be a fatal mistake to organize ARPA-H within the NIH,” said former assistant secretary of health Adm. Brett Giroir. “To a large extent, we need ARPA-H because the NIH cannot maintain a culture of radical innovation, disciplined execution, specific accountability, and streamlined processes that are essential for ARPA-H. . Don’t get me wrong – the NIH is exceptional at what it does, but it will never be DARPA or ARPA-H.
Dr. Keith Yamamoto, vice chancellor for science policy and strategy at the University of California, San Francisco, agreed, adding that the NIH must continue to thrive for ARPA-H to succeed. He called on Congress to establish safeguards to prevent ARPA-H funding from crowding out NIH investments or threatening its culture.
“An organization like ARPA-H exists to challenge conventional wisdom,” Yamamoto said. “Don’t put it inside the very organization that holds the conventional wisdom.”
On the other hand, the executive director of FasterCures and the Milken Institute’s Center for Public Health, Dr. Esther Krofah, argued that the NIH and ARPA-H may well co-exist, as the Department of Energy maintains its own advanced research agency, ARPA-e.
“We see no reason why ARPA-H could not be located within NIH and continue to accomplish its mission, including the benefits of having easy access to other infrastructure, personnel, programs, and NIH expertise,” Krofah said.
Beyond considerations of where to house ARPA-H, panelists offered further thoughts on how the new agency should be established. Several witnesses argued that ARPA-H program managers should have diverse backgrounds and shorter tenures, as well as implement streamlined and expeditious award processes, much like DARPA does. Giroir added that ARPA-H should also maintain a peer review process that resembles that of DARPA rather than the NIH.
On Demand Pharmaceuticals CEO and Johns Hopkins professor of neurology Dr. Geoggrey Shiu Fei Ling – who also founded DARPA’s Office of Biological Technologies – has argued that Congress needs to structure ARPA-H so that ‘it has ‘end-to-end’ processes, from exploring and conducting the science, regulating, then disseminating and understanding patient feedback.
To build an end-to-end model in ARPA-H’s programs, Krofah added that it will be essential for the agency to collaborate with other health agencies.
“The FDA is obviously a vital link in the process of putting exciting new science and new products into the hands of patients,” Krofah said. “We need to ensure they have the resources and expertise to keep pace and effectively regulate new technologies that come before them for consideration, through efforts such as ARPA-H. There must also be active and regular engagement with other agencies critical to advancing patient solutions, such as CMS and CDC.
Krofah also said ARPA-H should develop transparent, data-driven processes to establish its priorities and should invest in platform technologies and infrastructure to prepare for its formation. She also emphasized that ARPA-H staff and leadership should offer diverse backgrounds and expertise to help build equity in health innovations.
While all panelists supported ARPA-H overall, Johns Hopkins Professor of Medicine Dr. Brian Miller said ARPA-H is not enough to keep up with the contradictory progress of research and development, such as those occurring in China.
“The market capitalization of Chinese companies’ biopharmaceutical companies has grown from 3 billion to 380 billion, a 100-fold increase over the past five years,” Miller said. “There were 23 Chinese life sciences IPOs in 2020. Of the world’s largest life sciences IPOs, seven out of 10 were from China. China has more researchers than us and more patents issued. … So ARPA-H is really not enough if we want to respond to China. We must protect our greatest achievement, which is our biomedical research industrial complex.
Among the panel’s contributions for lawmakers to consider in defending ARPA-H, lawmakers introduced legislation that would fund the new agency $3 billion in the House and $2.4 billion in the Senate. The next steps in funding ARPA-H depend on the subcommittee drafting and passing authorizing legislation, committee chairman Rep. Frank Pallone said.